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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Suppliers Guide

The suppliers guide is a resource of services and solutions for regulatory affairs professionals and their companies. Listings do not imply a product or service endorsement by RAPS.

Suppliers interested in adding their services to the guide can contact RAPS at advertising@raps.org.

Company

Business Type

Location

Asia Actual LLC
Asia Actual specializes in the registration and compliance of medical and diagnostic devices in Asian markets. Experienced, local regulatory experts work closely with clients to address even the most challenging novel and high-risk device registrations. We provide transparent and efficient support in otherwise complex markets.

Consulting

Austin, Texas

A Wright Path, Inc
A Wright Path’s experienced team will execute and navigate the FDA and global regulatory requirements and submissions so you can launch your product into the marketplace confidently.

Bennett and Company
Bennett and Company provides a variety of regulatory and quality system consulting services to companies...

Consulting Services
Hospital/Medical Practice
Legal

Alexandria, Virginia

Brandwood Biomedical
Brandwood Biomedical is a Quality, Regulatory and Reimbursement consultancy headquartered in Sydney with an international office network and a solid track record of excellence of over 20 years.

Consulting
Quality Assurance

Sydney, Australia

CJP Consulting, Inc.
CJP Consulting, Inc. develops and updates corporate quality systems, prepares and submits class II medical device 510(k) applications, prepares companies for FDA inspections and Joint Commission accreditation surveys, and provides ongoing regulatory advice and support. CJP Consulting is based in Chicago, IL and has clients across the U.S. Services are customized to fit the needs of the client to ensure complete satisfaction every time.

Consulting Services

Chicago, Illinois

Commissioning Agents, Inc.
CAI knows quality and risk control systems (FMEA, HACCP) that form the basis of current GMP in drug and food manufacturing.

Consulting Services

Indianapolis, Indiana

DEKRA Certification
DEKRA Certification is a world-class Notified Body, with offices in the US, The Netherlands, Germany,...

Concord , California

dicentra
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries...

Fang Consulting, LTD.
At Fang, we specialize in Regulatory Affairs Consulting and Quality System Consulting for the medical device community.

Consulting Services

Minneapolis, Minnesota

G&L Scientific
Founded on the principle of great people backed by great customer service, G&L Scientific is a market leading, multinational, scientific consultancy with over 20 years of deep domain experience in the fields of Regulatory Affairs and Quality Assurance.

Hogan Lovells
Hogan Lovells operates on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and streamline regulatory approvals.

Consulting Services

Washington, DC

HartmannWillner LLC
Since 2009 we have advanced the development of over 130 products. We are a boutique FDA biologics consulting group specializing in biologics, biosimilars, biotechnology, and biologic device combination products.

Consulting Services

Washington DC

Lachman Consultant Services Inc.
Lachman Consultant Services Inc. (LCS), founded in 1978, is a worldwide leading provider of expert technical, compliance and regulatory services in all FDA-related areas.

Consulting Services

Westbury, New York

MasterControl
MasterControl’s integrated solutions accelerate ROI and increase efficiencies by automating and securely managing critical business processes throughout the entire product lifecycle. More than 1,000 companies worldwide, ranging in size from five employees to tens of thousands, rely on MasterControl cloud solutions to automate processes for new product development, clinical, regulatory, quality management, supplier management, manufacturing and post-market surveillance. MasterControl solutions are well-known for being scalable, easy to implement, easy to validate and easy to use.

Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

RegIQ Solutions is the developer of Magellan, a sophisticated regulatory guidance SaaS platform for medical devices and diagnostics. It features comprehensive, device-specific intelligence in 60 countries and 10 global regions, on-board project management to keep regulatory team members aligned, on task and on budget, a document manager for document review and tracking and a license manager with pro-active alerts to keep licenses active and current.

RWS Life Sciences is a leading global provider of language solutions exclusively for life sciences. We have built a reputation of excellence for solving the most complex and demanding multilingual challenges in the areas of clinical trial management; regulatory affairs; medical devices; linguistic validation; E-learning and training; and marketing communications.